Overview

This trial is active, not recruiting.

Condition malaria
Treatments glaxosmithkline (gsk) biologicals' candidate plasmodium falciparum malaria vaccine 257049, engerix-b™ vaccine, infanrix/hib™ vaccine, polio sabin™ vaccine, rotarix™ vaccine, synflorix™ vaccine, measles vaccine, yellow fever vaccine
Phase phase 3
Sponsor GlaxoSmithKline
Start date November 2011
End date January 2013
Trial size 705 participants
Trial identifier NCT01345240, 113681

Summary

This study has been designed to support the indication of the candidate vaccine (also referred to as GSK 257049 or RTS,S in this record) against hepatitis B virus infection, when administered as a primary vaccination integrated into an Expanded Program on Immunization (EPI) regimen to infants living in sub-Saharan Africa.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the RTS,S Vaccination Regimen A, with the RTS,S vaccine administered in its Lot 1 formulation. This RTS,S Vaccination Regimen A included 3 doses of RTS,S vaccine, Lot 1, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
glaxosmithkline (gsk) biologicals' candidate plasmodium falciparum malaria vaccine 257049
Children enrolled in 9 groups will receive 3 doses of the candidate malaria vaccine (Lot 1, 2 and 3) by intramuscular injection.
engerix-b™ vaccine
Children enrolled in 2 groups will receive 4 doses of Engerix-B™ vaccine by intramuscular injection. Children enrolled in all other groups will receive one dose of Engerix-B vaccine by intramuscular injection.
infanrix/hib™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Infanrix/Hib™ vaccine by intramuscular injection
polio sabin™ vaccine
Children enrolled in all 11 groups will receive 3 doses of Polio Sabin™ by intramuscular injection.
rotarix™ vaccine
Children enrolled in all 11 groups will receive 2 doses of oral Rotarix™ vaccine.
synflorix™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Synflorix™ vaccine by intramuscular injection.
measles vaccine
Children enrolled in all 11 groups will receive 1 dose of measles vaccine by intramuscular injection.
yellow fever vaccine
Children enrolled in all 11 groups will receive 1 dose of yellow fever vaccine by intramuscular injection.
(Experimental)
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the RTS,S Vaccination Regimen A, with the RTS,S vaccine administered in its Lot 2 formulation. This RTS,S Vaccination Regimen A included 3 doses of RTS,S vaccine, Lot 2, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
glaxosmithkline (gsk) biologicals' candidate plasmodium falciparum malaria vaccine 257049
Children enrolled in 9 groups will receive 3 doses of the candidate malaria vaccine (Lot 1, 2 and 3) by intramuscular injection.
engerix-b™ vaccine
Children enrolled in 2 groups will receive 4 doses of Engerix-B™ vaccine by intramuscular injection. Children enrolled in all other groups will receive one dose of Engerix-B vaccine by intramuscular injection.
infanrix/hib™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Infanrix/Hib™ vaccine by intramuscular injection
polio sabin™ vaccine
Children enrolled in all 11 groups will receive 3 doses of Polio Sabin™ by intramuscular injection.
rotarix™ vaccine
Children enrolled in all 11 groups will receive 2 doses of oral Rotarix™ vaccine.
synflorix™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Synflorix™ vaccine by intramuscular injection.
measles vaccine
Children enrolled in all 11 groups will receive 1 dose of measles vaccine by intramuscular injection.
yellow fever vaccine
Children enrolled in all 11 groups will receive 1 dose of yellow fever vaccine by intramuscular injection.
(Experimental)
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the RTS,S Vaccination Regimen A, with the RTS,S vaccine administered in its Lot 3 formulation. This RTS,S Vaccination Regimen A included 3 doses of RTS,S vaccine, Lot 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
glaxosmithkline (gsk) biologicals' candidate plasmodium falciparum malaria vaccine 257049
Children enrolled in 9 groups will receive 3 doses of the candidate malaria vaccine (Lot 1, 2 and 3) by intramuscular injection.
engerix-b™ vaccine
Children enrolled in 2 groups will receive 4 doses of Engerix-B™ vaccine by intramuscular injection. Children enrolled in all other groups will receive one dose of Engerix-B vaccine by intramuscular injection.
infanrix/hib™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Infanrix/Hib™ vaccine by intramuscular injection
polio sabin™ vaccine
Children enrolled in all 11 groups will receive 3 doses of Polio Sabin™ by intramuscular injection.
rotarix™ vaccine
Children enrolled in all 11 groups will receive 2 doses of oral Rotarix™ vaccine.
synflorix™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Synflorix™ vaccine by intramuscular injection.
measles vaccine
Children enrolled in all 11 groups will receive 1 dose of measles vaccine by intramuscular injection.
yellow fever vaccine
Children enrolled in all 11 groups will receive 1 dose of yellow fever vaccine by intramuscular injection.
(Experimental)
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the RTS,S Vaccination Regimen B, with the RTS,S vaccine administered in its Lot 1 formulation. This RTS,S Vaccination Regimen B included 3 doses of RTS,S vaccine, Lot 1, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
glaxosmithkline (gsk) biologicals' candidate plasmodium falciparum malaria vaccine 257049
Children enrolled in 9 groups will receive 3 doses of the candidate malaria vaccine (Lot 1, 2 and 3) by intramuscular injection.
engerix-b™ vaccine
Children enrolled in 2 groups will receive 4 doses of Engerix-B™ vaccine by intramuscular injection. Children enrolled in all other groups will receive one dose of Engerix-B vaccine by intramuscular injection.
infanrix/hib™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Infanrix/Hib™ vaccine by intramuscular injection
polio sabin™ vaccine
Children enrolled in all 11 groups will receive 3 doses of Polio Sabin™ by intramuscular injection.
rotarix™ vaccine
Children enrolled in all 11 groups will receive 2 doses of oral Rotarix™ vaccine.
synflorix™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Synflorix™ vaccine by intramuscular injection.
measles vaccine
Children enrolled in all 11 groups will receive 1 dose of measles vaccine by intramuscular injection.
yellow fever vaccine
Children enrolled in all 11 groups will receive 1 dose of yellow fever vaccine by intramuscular injection.
(Experimental)
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the RTS,S Vaccination Regimen B, with the RTS,S vaccine administered in its Lot 2 formulation. This RTS,S Vaccination Regimen B included 3 doses of RTS,S vaccine, Lot 2, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
glaxosmithkline (gsk) biologicals' candidate plasmodium falciparum malaria vaccine 257049
Children enrolled in 9 groups will receive 3 doses of the candidate malaria vaccine (Lot 1, 2 and 3) by intramuscular injection.
engerix-b™ vaccine
Children enrolled in 2 groups will receive 4 doses of Engerix-B™ vaccine by intramuscular injection. Children enrolled in all other groups will receive one dose of Engerix-B vaccine by intramuscular injection.
infanrix/hib™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Infanrix/Hib™ vaccine by intramuscular injection
polio sabin™ vaccine
Children enrolled in all 11 groups will receive 3 doses of Polio Sabin™ by intramuscular injection.
rotarix™ vaccine
Children enrolled in all 11 groups will receive 2 doses of oral Rotarix™ vaccine.
synflorix™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Synflorix™ vaccine by intramuscular injection.
measles vaccine
Children enrolled in all 11 groups will receive 1 dose of measles vaccine by intramuscular injection.
yellow fever vaccine
Children enrolled in all 11 groups will receive 1 dose of yellow fever vaccine by intramuscular injection.
(Experimental)
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the RTS,S Vaccination Regimen B, with the RTS,S vaccine administered in its Lot 3 formulation. This RTS,S Vaccination Regimen B included 3 doses of RTS,S vaccine, Lot 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
glaxosmithkline (gsk) biologicals' candidate plasmodium falciparum malaria vaccine 257049
Children enrolled in 9 groups will receive 3 doses of the candidate malaria vaccine (Lot 1, 2 and 3) by intramuscular injection.
engerix-b™ vaccine
Children enrolled in 2 groups will receive 4 doses of Engerix-B™ vaccine by intramuscular injection. Children enrolled in all other groups will receive one dose of Engerix-B vaccine by intramuscular injection.
infanrix/hib™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Infanrix/Hib™ vaccine by intramuscular injection
polio sabin™ vaccine
Children enrolled in all 11 groups will receive 3 doses of Polio Sabin™ by intramuscular injection.
rotarix™ vaccine
Children enrolled in all 11 groups will receive 2 doses of oral Rotarix™ vaccine.
synflorix™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Synflorix™ vaccine by intramuscular injection.
measles vaccine
Children enrolled in all 11 groups will receive 1 dose of measles vaccine by intramuscular injection.
yellow fever vaccine
Children enrolled in all 11 groups will receive 1 dose of yellow fever vaccine by intramuscular injection.
(Experimental)
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the RTS,S Vaccination Regimen C, with the RTS,S vaccine administered in its Lot 1 formulation. This RTS,S Vaccination Regimen C included 3 doses of RTS,S vaccine, Lot 1, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
glaxosmithkline (gsk) biologicals' candidate plasmodium falciparum malaria vaccine 257049
Children enrolled in 9 groups will receive 3 doses of the candidate malaria vaccine (Lot 1, 2 and 3) by intramuscular injection.
engerix-b™ vaccine
Children enrolled in 2 groups will receive 4 doses of Engerix-B™ vaccine by intramuscular injection. Children enrolled in all other groups will receive one dose of Engerix-B vaccine by intramuscular injection.
infanrix/hib™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Infanrix/Hib™ vaccine by intramuscular injection
polio sabin™ vaccine
Children enrolled in all 11 groups will receive 3 doses of Polio Sabin™ by intramuscular injection.
rotarix™ vaccine
Children enrolled in all 11 groups will receive 2 doses of oral Rotarix™ vaccine.
synflorix™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Synflorix™ vaccine by intramuscular injection.
measles vaccine
Children enrolled in all 11 groups will receive 1 dose of measles vaccine by intramuscular injection.
yellow fever vaccine
Children enrolled in all 11 groups will receive 1 dose of yellow fever vaccine by intramuscular injection.
(Experimental)
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the RTS,S Vaccination Regimen C, with the RTS,S vaccine administered in its Lot 2 formulation. This RTS,S Vaccination Regimen C included 3 doses of RTS,S vaccine, Lot 2, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
glaxosmithkline (gsk) biologicals' candidate plasmodium falciparum malaria vaccine 257049
Children enrolled in 9 groups will receive 3 doses of the candidate malaria vaccine (Lot 1, 2 and 3) by intramuscular injection.
engerix-b™ vaccine
Children enrolled in 2 groups will receive 4 doses of Engerix-B™ vaccine by intramuscular injection. Children enrolled in all other groups will receive one dose of Engerix-B vaccine by intramuscular injection.
infanrix/hib™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Infanrix/Hib™ vaccine by intramuscular injection
polio sabin™ vaccine
Children enrolled in all 11 groups will receive 3 doses of Polio Sabin™ by intramuscular injection.
rotarix™ vaccine
Children enrolled in all 11 groups will receive 2 doses of oral Rotarix™ vaccine.
synflorix™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Synflorix™ vaccine by intramuscular injection.
measles vaccine
Children enrolled in all 11 groups will receive 1 dose of measles vaccine by intramuscular injection.
yellow fever vaccine
Children enrolled in all 11 groups will receive 1 dose of yellow fever vaccine by intramuscular injection.
(Experimental)
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the RTS,S Vaccination Regimen C, with the RTS,S vaccine administered in its Lot 3 formulation. This RTS,S Vaccination Regimen C included 3 doses of RTS,S vaccine, Lot 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
glaxosmithkline (gsk) biologicals' candidate plasmodium falciparum malaria vaccine 257049
Children enrolled in 9 groups will receive 3 doses of the candidate malaria vaccine (Lot 1, 2 and 3) by intramuscular injection.
engerix-b™ vaccine
Children enrolled in 2 groups will receive 4 doses of Engerix-B™ vaccine by intramuscular injection. Children enrolled in all other groups will receive one dose of Engerix-B vaccine by intramuscular injection.
infanrix/hib™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Infanrix/Hib™ vaccine by intramuscular injection
polio sabin™ vaccine
Children enrolled in all 11 groups will receive 3 doses of Polio Sabin™ by intramuscular injection.
rotarix™ vaccine
Children enrolled in all 11 groups will receive 2 doses of oral Rotarix™ vaccine.
synflorix™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Synflorix™ vaccine by intramuscular injection.
measles vaccine
Children enrolled in all 11 groups will receive 1 dose of measles vaccine by intramuscular injection.
yellow fever vaccine
Children enrolled in all 11 groups will receive 1 dose of yellow fever vaccine by intramuscular injection.
(Active Comparator)
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
engerix-b™ vaccine
Children enrolled in 2 groups will receive 4 doses of Engerix-B™ vaccine by intramuscular injection. Children enrolled in all other groups will receive one dose of Engerix-B vaccine by intramuscular injection.
infanrix/hib™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Infanrix/Hib™ vaccine by intramuscular injection
polio sabin™ vaccine
Children enrolled in all 11 groups will receive 3 doses of Polio Sabin™ by intramuscular injection.
rotarix™ vaccine
Children enrolled in all 11 groups will receive 2 doses of oral Rotarix™ vaccine.
synflorix™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Synflorix™ vaccine by intramuscular injection.
measles vaccine
Children enrolled in all 11 groups will receive 1 dose of measles vaccine by intramuscular injection.
yellow fever vaccine
Children enrolled in all 11 groups will receive 1 dose of yellow fever vaccine by intramuscular injection.
(Active Comparator)
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
engerix-b™ vaccine
Children enrolled in 2 groups will receive 4 doses of Engerix-B™ vaccine by intramuscular injection. Children enrolled in all other groups will receive one dose of Engerix-B vaccine by intramuscular injection.
infanrix/hib™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Infanrix/Hib™ vaccine by intramuscular injection
polio sabin™ vaccine
Children enrolled in all 11 groups will receive 3 doses of Polio Sabin™ by intramuscular injection.
rotarix™ vaccine
Children enrolled in all 11 groups will receive 2 doses of oral Rotarix™ vaccine.
synflorix™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Synflorix™ vaccine by intramuscular injection.
measles vaccine
Children enrolled in all 11 groups will receive 1 dose of measles vaccine by intramuscular injection.
yellow fever vaccine
Children enrolled in all 11 groups will receive 1 dose of yellow fever vaccine by intramuscular injection.

Primary Outcomes

Measure
Anti-Hepatitis B (HBs) Antibody Concentrations
time frame: At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B™
Anti-Hepatitis B (HBs) Antibody Concentrations.
time frame: At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B™

Secondary Outcomes

Measure
Anti-Hepatitis B (HBs) Antibody Concentrations
time frame: At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B™
Anti-Hepatitis B (HBs) Antibody Concentrations.
time frame: At Month 51, aka one month post the Month 50 booster dose of Engerix-B™
Anti-Hepatitis B (HBs) Antibody Concentrations.
time frame: At Months 14, 26, 38 and 50, aka at 12, 24, 36 and 48 months post Dose 3 of RTS,S vaccine or Engerix-B™
Concentrations of Antibodies to the Hepatitis B RF1 Surface Antigen (Anti-HBs RF1).
time frame: At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B™
Concentrations of Antibodies to the Hepatitis B RF1 Surface Antigen (Anti-HBs RF1).
time frame: At Month 51, aka one month post the Month 50 booster dose of Engerix-B™
Anti-circumsporozoite Protein (Anti-CS) Antibody Concentrations
time frame: At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B™
Anti-circumsporozoite Protein (Anti-CS) Antibody Concentrations .
time frame: At Months 14, 26, 38 and 50, aka at 12, 24, 36 and 48 months post Dose 3 of RTS,S vaccine or Engerix-B™
Pneumococcal Antibody Concentrations Against Synflorix™ Pneumococcal Vaccine Serotypes.
time frame: At Month 3, aka at one month post Dose 3 of Synflorix™
Pneumococcal Antibody Concentrations Against Synflorix™ Pneumococcal Vaccine Serotypes.
time frame: At Month 17, aka one month post the Month 16 booster dose of Synflorix™
Titers for Opsonophagocytic Activity Against Synflorix™ Pneumococcal Vaccine Serotypes.
time frame: At Month 3, aka at one month (1M) post Dose 3 of Synflorix™
Titers for Opsonophagocytic Activity Against Synflorix™ Pneumococcal Vaccine Serotypes.
time frame: At Month 17, aka one month post the Month 16 booster dose of Synflorix™
Anti-protein D (PD) Antibody Concentrations
time frame: At Month 3, aka at one month post Dose 3 of Synflorix™
Anti-protein D (PD) Antibody Concentrations
time frame: At Month 17, aka one month post the Month 16 booster dose of Synflorix™
Concentrations of Antibodies Against Acellular B-pertussis (BPT)
time frame: At Day 0 and at one month post Dose 3 of Infanrix™-Hib
Anti-Rotavirus (Anti-RV) Antibody Concentrations
time frame: At Month 3, aka one month post Dose 2 of Rotarix™
Number of Subjects With Solicited Local Symptoms
time frame: Within the 7-day follow-up period (Days 0-6) after administration of Dose (D) 1, 2 and 3, respectively, with RTS,S or Engerix-B™ vaccine
Number of Subjects With Solicited General Symptoms
time frame: Within the 7-day follow-up period (Days 0-6) after administration of Dose (D) 1, 2 and 3, respectively, with RTS,S or Engerix-B™ vaccine
Number of Subjects With Potential Immune Mediated Disorders (pIMDs)
time frame: From Day 0 to Month 8.
Number of Subjects With Potential Immune Mediated Disorders (pIMDs)
time frame: From study start at Day 0 to study end at Month 51
Number of Subjects With Unsolicited Adverse Events (AEs)
time frame: Within the 30-day follow-up periods (Days 0-29) after vaccination with RTS,S vaccine or Engerix-B™
Number of Subjects With Any and Fatal Serious Adverse Events (SAEs)
time frame: Within the 30-day follow-up periods (Days 0-29) after vaccination with RTS,S vaccine or Engerix-B™
Number of Subjects With Any and Fatal Serious Adverse Events (SAEs)
time frame: From Day 0 to Month 8
Number of Subjects With Any and Fatal Serious Adverse Events (SAEs)
time frame: From Day 0 to Study End at Month 51

Eligibility Criteria

Male or female participants from 8 weeks up to 12 weeks old.

Inclusion Criteria: All subjects must satisfy ALL the following criteria at study entry: - A male or female infant aged between 8 and 12 weeks inclusive at the time of first vaccination - Signed or thumb-printed informed consent obtained from the parent(s)/Legally Acceptable Representative [LAR(s)] of the child. Where parent(s)/LAR(s) are illiterate, the consent form will be countersigned by an independent witness - Subjects who the investigator believes that their parent(s)/LAR(s) can and will comply with the requirements of the protocol - Healthy subjects as established by medical history and clinical examination before entering into the study - Born to a mother who is Hepatitis B surface antigen (HBsAg) negative - Born to a mother who is Human Immunodeficiency Virus (HIV) negative - Born after a normal gestation period of 36 to 42 weeks inclusive. Exclusion Criteria: The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study: - Child in care - Acute disease and/or fever at the time of enrolment - Serious acute or chronic illness determined by clinical or physical examination and laboratory screening tests - Laboratory screening tests out of range - Previous vaccination with diphtheria, tetanus, pertussis, Haemophilus influenzae type b, Streptococcus pneumoniae, hepatitis B vaccine or rotavirus vaccines. - Planned administration/administration of a licensed vaccine not foreseen by the study protocol within 7 days of the first dose of study vaccine. - Use of a drug or vaccine that is not approved for that indication other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period. - Administration of immunoglobulins and/or any blood products in the period between birth and Dose 1 and within the three months preceding planned vaccine administration during the study period. - Chronic administration of immunosuppressants or other immune-modifying drugs in the period between birth and Dose 1. - Concurrently participating in another clinical study at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. - Same sex twin - Maternal death - History of allergic reactions or anaphylaxis to previous immunizations. - History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. - Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial. - Any other findings that the investigator feels would result in data collected being incomplete or of poor quality. - Previous participation in any other malaria vaccine trial.

Additional Information

Official title Immunogenicity of the Hepatitis B Antigen of the GSK Biologicals' Candidate Malaria Vaccine (257049)
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by GlaxoSmithKline.